Kornimate/medical-research-clean huggingface dataset:
a biologic validation of biomarkers of progressive nec & sepsis

Conditions: Necrotizing Enterocolitis

Summary: necrotizing enterocolitis (nec) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. if it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. parts or all of the intestine may die. despite 30 years of clinical studies, the cause of nec remains unknown. in this study, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.


Eligibility criteria:
inclusion criteria - nec/sepsis cohort ga \< 29 weeks current age equal or \<12 weeks suspicion of nec or sepsis exclusion - nec/sepsis cohort current or prior diagnosis of nec early onset infection (equal or \<72 hours of life) previous diagnosis of sepsis within 7 days previous abdominal surgery significant congenital anomaly inclusion criteria - sip cohort infants born at \<29 weeks gestation equal to or \<12 weeks of age at the time of eligibility assessment a decision to perform surgery (or drain) for suspected nec or sip exclusion - sip cohort congenital infection (equal to \<72 hours of life) prior episode of nec or sip prior laparotomy or drain for sip or nec

Keywords: necrotizing enterocolitis progressive necrotizing enterocolitis proteomics in blood genomics in blood multi-center
an observational, prospective study to assess the efficacy and safety of adalloce in patients with ra and as

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis

Summary: this study is to assess the efficacy and safety of adalloce in patients with rheumatoid arthritis and ankylosing spondylitis, an observational, prospective study


Eligibility criteria:
inclusion criteria: 1. men and women between the ages of over 19 and under 75 at the time of consent 2. patients diagnosed with ra or as at least 3 months prior to the study registration 3. patients who are scheduled to be prescribed adalloce according to the doctor's opinions 4. patients who have never received adalloce 5. patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study exclusion criteria: 1. patients with hypersensitivity to this drug or its components 2. patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection 3. patients with moderate to severe heart failure (nyha class iii/iv) 4. patients who are judged to be inappropriate for adalloce administration according to the approved conditions 5. patients who are not suitable for participation in this study according to the judgment of the investigator 6. patients participating in other drug clinical trials (adalloce pms participants cannot participate in this study)

Keywords: the efficacy and safety of adalloce
a study of lu ag06466 in participants with treatment resistant focal epilepsy

Conditions: Focal Epilepsy

Summary: the main purpose of this study is to investigate effects of lu ag06466 on seizure activity after increasing daily doses during 4 weeks in participants with an implanted responsive neurostimulation system.

this crossover study consists of 2 treatment periods, each of 29 days duration. on day -1 of treatment period 1, eligible participants will be randomized (1:1) to a sequence of treatments (either lu ag06466-placebo or placebo-lu ag06466).

Eligibility criteria:
key inclusion criteria: * the participant must have had the responsive neurostimulation system (rns®) system implanted for more than 1 year and medically intractable focal onset epileptic seizures (history of persistent seizures refractory to 2 or more anti-epileptic drugs \[aeds\]), with seizures from all foci represented in the implanted rns electrodes. * the participant is required to have a continuous period of at least 2 months prior to the screening visit with constant rns stimulation settings as well as stable aed (that is, 60 days with no dose adjustments of more than 25%) as determined by medical history and the patient data management system (pdms). there must be at least 24 recorded long episodes available for review since last change of rns detection setting. * the participant is required to have approximately 7 or more long episodes per week, as assessed as an average over the last 2 months prior to the screening visit. * the participant is required to have a demonstrated history of compliance with rns scanning and uploading procedure in the past year (less than 20% missing long episode counts on the pdms). key exclusion criteria: * the participant has the rns system implanted in other regions than the epileptic foci such as the thalamus. * the participant has a rns system with anticipated generator change in the coming 6 months. * the participant has a cyclic pattern of long episodes in the last 2 months prior to the screening visit which exhibits, in the opinion of the investigator: a period of more than 3 weeks; and peak-to-trough differences of long episodes of more than half the peak level. * the participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological (apart from epileptic diagnosis), or psychiatric disease or other major disorder, which in opinion of the investigator may influence efficacy or safety aspects in the study. other inclusion and exclusion criteria may apply.
the effect of diuresis during 20-minute pad test on the estimation of the severity of stress urinary incontinence

Conditions: Lower Urinary Tract Symptoms

Summary: the aim of this study is to estimate the amount of extra urine produced by natural diuresis during 20-minute pad test, and assess the effect of diuresis on the accuracy of using 20-minute pad test to estimate the severity of sui. besides, the above results may be used for further refinement of the amount of water infusion used for the 20-minute pad test.

pad testing is an important method to evaluate the severity of women with stress urinary incontinence (sui). the investigators had proved the superiority of the infusion of the strong desire amount while using 20-minute pad test for detecting sui. however, a considerable volume of urine may be produced by natural diuresis during the course of 20-minute pad test with strong-desire amount infusion, and may cause bladder overdistension, more urine leakage and overestimate the severity of sui. thus, the aim of this study is to estimate of the amount of extra urine produced by natural diuresis, and assess its effect on the ability of using pad weight to estimate the severity of sui. the investigators will review the clinical data of patients who receiving urodynamic studies in the department of obstetrics \& gynecology of national taiwan university hospital between january 2008 and march 2014. stata 11.0 software will be used for statistical analysis. the investigators will get the mean values of diuresis, and the factors affecting the amount of diuresis. besides, the investigators can get the influence of diuresis on the accuracy of 20-minute pad test as a role of estimating the severity of sui. the above data should be important for further refinement of 20-minute pad test.

Eligibility criteria:
inclusion criteria: * more than 20-year-old woman who with stress urinary incontinence (sui). * we will review the clinical data, urodynamics, pad weight and bladder diary of patients who receiving urodynamic studies and 20-minute pad test in the department of obstetrics \& gynecology of national taiwan university hospital between january 2008 and march 2014. exclusion criteria: * \< 20 year old female

Keywords: lower urinary tract symptoms urodynamic studies diuresis
mri to assess fibrosis in eosinophilic esophagitis patients

Conditions: Eosinophilic Esophagitis

Summary: can an mri detect and monitor the inflammatory and fibrotic possess in patients with eosinophilic esophagitis

mri will be performed on a 1.5t magnet. patients will be scanned in an oblique prone position similar to how esophageal distention is assessed at barium fluoroscopy. the following sequences and rationale will be used for the examination: a sagittal 50mm thick multiphase fiesta and multiphase ssfse will be performed while the patient drinks water. the temporal resolution of the images will be approximately 1 image every 1.5-2 seconds. the images will be used to assess the lumen caliber and the wall thickness during maximal distension as pseudothickening can occur with decreased luminal distension. sagittal ssfse with fat suppression, sagittal frfse t2-weighted images with fat suppression, axial dwi and sagittal dwi will be performed to asses for edema and inflammation within the esophageal wall. axial fs ssfse or fiesta will be performed and targeted to the region of stricturing. dynamic sagittal imaging will be performed following iv contrast to assess for mural hyperenhancement which can be seen mural inflammation and delayed enhancement which can be seen in fibrosis. sequential acquisitions will be performed beginning at 40 seconds following iv contrast injection. delayed acquisitions will be performed at 5 min and 7 min. patients will be asked to perform swallowing during the image acquisition to reduce the potential for pseudoenhancement secondary to under distension.

Eligibility criteria:
inclusion criteria: * adults ages 18-70 years of age * diagnosis of eoe, i.e. symptoms of esophageal dysfunction with histologic finding of 15 or more eosinophils per high power field on esophageal biopsy despite 8 weeks of high dose proton pump inhibitor therapy. * all subjects diagnosed with eosinophilic esophagitis pre and pose therapy exclusion criteria: * clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, cmv, herpes) * other cause of dysphagia identified at endoscopy or esophagram (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm) * esophageal minimal diameter \< 13 mm on structured barium esophagram * inability to read due to: blindness, cognitive dysfunction, or english language illiteracy * pregnant women * presence of body metallic fragments or devices that prohibit use of mri * history of renal disease * egrf \<30

Keywords: eoe
the neurocircuitry of relief during avoidance learning in patients with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: to investigate the neuro-mechanisms underpinning persistent avoidance in ocd patients

many compulsions displayed by obsessive-compulsive disorder (ocd) patients serve to protect against perceived threat and can, therefore, be conceptualized as 'avoidance responses'. exposure treatment with response prevention (et+rp) is aimed at exposing patients to their obsessive thoughts and perceived threats while preventing engagement in compulsive avoidant responses. this induces extinction of threat perception and fearful arousal and hence reduces the motivation to avoid. while successful in many patients, however, as much as 40% dropout during treatment or display persistent avoidance after et+rp. there is a clear need for treatment improvement for these often highly disabled patients. improving et+rp outcomes requires a deeper understanding of the mechanisms that drive excessive and persistent avoidance in ocd patients. psychological theories ascribe an important role to the relief that follows avoidance when the anticipated threat is successfully averted. this positive feeling arguably functions as a reward to reinforce the foregoing avoidance actions. indeed, fmri studies have found that the neurocircuitry of relief overlaps with that of reward, including the ventral tegmental area, ventral striatum and orbitofrontal cortex. here, the authors will test the hypothesis that excessive-persistent avoidance is linked to exaggerated activation of the relief circuitry in ocd patients. for that purpose, we will acquire functional brain images of ocd patients in an mri scanner and compare to healthy participants, while they participate in a computer task that is designed to model avoidance learning and relief.

Eligibility criteria:
inclusion criteria: * healthy volunteers 18-60 years old; * participants are motivated and give written informed consent; * adequate demand of dutch language; * subjects have never participated in a fear conditioning task; * diagnosis of ocd (for ocd group only); * contraindications for the mri exam. exclusion criteria: * current neurological (e.g. epilepsia), respiratory, cardiovascular, metabolic, gastrointestinal, endocrine (especially diabetes), renal or urinary diseases, psychiatric disorder or other relevant medical histories (except for ocd in the ocd group); * being pregnant or lactating; * alcohol intake greater than 14 alcoholic units per week (one alcoholic unit = 10 gr ethanol); * history of cannabis use or any other drug of abuse during the 3 months prior to the study; * the medical doctor has asked to the participant to stay away from stressful situations; * electronic implants (e.g., pacemaker); * pain or other condition of the hand or the wrist.

Keywords: avoidance behavior reward conditioning extinction anxiety disorders ocd fmri
training in ataxia - individuals with degenerative cerebellar diseases

Conditions: Cerebellar Ataxia

Summary: balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. the goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.

degenerative cerebellar diseases are a group of disorders that cause severe disability and can be fatal. there are currently no known disease-modifying treatments available for use, and there is a critical need to find treatments that slow disease progression and allow affected individuals to live more functional lives. balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods have not been thoroughly investigated. it is crucial to understand how the training impacts the brain, and particularly the cerebellum, in order to determine if one training method is better at slowing disease progression than the other. the goal of this proposal is to compare the neural effects of balance versus aerobic training in individuals with degenerative cerebellar diseases. the investigator hypothesizes that aerobic training causes neuroplastic changes within the cerebellum whereas balance training causes improvements for people with cerebellar degeneration by impacting brain structures outside the cerebellum. if this hypothesis is true, aerobic training may have more influence on disease progression than balance training as it directly impacts the cerebellum. to investigate the hypothesis, various neuroimaging techniques will be used. in aim 1, the investigator will compare cerebellar volume before and after the participants perform either 6-months of balance or aerobic training. in aim 2, the investigator will investigate whether neural changes have clinical significance by correlating cerebellar volume changes with clinical measures of ataxia. finally, for aim 3, the investigator will use diffusion tensor imaging and resting state fmri scans to examine how both training methods impact cerebellar microstructure and functional cerebellar connections. the investigator hopes that a detailed understanding of how each training method impacts the cerebellum will lead to more targeted training regimens with the goal of slowing disease progression of these devastating diseases.

Eligibility criteria:
inclusion criteria: * diagnosed with spinocerebellar ataxia * cerebellar atrophy on mri * prevalence of ataxia on clinical exam * ability to safely ride a stationary exercise bike exclusion criteria: * other neurologic conditions * heart disease * cognitive impairment * medical instability

Keywords: ataxia cerebellar ataxia exercise training rehabilitation
effect of cox-2 selective inhibitors on postoperative insulin resistance after gastrointestinal laparoscopic surgery

Conditions: Gastrointestinal Cancer

Summary: it is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. this condition is known as insulin resistance (ir) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. surgical ir not only affect glucose metabolism but also influence protein synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein. postoperative pain is a challenging task for patients and surgeons, and it is part of the stress response to trauma and surgery, while the fear of pain can exacerbate the stress response. the main aim of this study was to invest whether effective postoperative analgesia can reduce the stress response and insulin resistance.


Eligibility criteria:
inclusion criteria: * patients with gastrointestinal cancer scheduled for gastrointestinal laparoscopic surgery * patients between the ages of 18 and 70 yr * asa physical status i-ii * requirements of informed consent and assent of participant, parent or legal guardian as applicable * consciousness and ability to cooperate exclusion criteria： * history of alcohol, analgesic, or narcotic abuse * used analgesics, neuroleptics, antipsychotic agents, or corticosteroids within 6 hours of surgery * a clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease * female with positive pregnancy * allergy to conventional nsaids
lidocaine administration during flexible bronchoscopy and endobronchial ultrasound

Conditions: Bronchiectasis Adult; Mediastinal Lymphadenopathy; Pneumonia; Chest--Diseases; Infiltrates; Bronchopulmonary Disease; Cancer, Lung

Summary: the purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. the modes of administration being evaluated are topical, nebulized and atomized.


Eligibility criteria:
inclusion criteria: * diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration. * diagnosis of pulmonary disease requiring flexible bronchoscopy * greater than 18 years of age. exclusion criteria: * any intervention beyond flexible bronchoscopy and endobronchial ultrasound * inability to tolerate bronchoscopy. * patients that receive paralytics. * patients with neuromuscular diseases. * inability to consent for procedures. * allergies to lidocaine or any other drugs used in protocol. * existing renal insufficiency or liver disease
nasal continuous positive airway pressure (cpap) in chronic fatigue and sleep-disordered breathing

Conditions: Chronic Fatigue With OSA; Chronic Fatigue Syndrome With OSA

Summary: chronic fatigue (cf) and chronic fatigue syndrome (cfs) are disabling disorders that may be induced or aggravated by underlying sleep disturbances. the relationship between sleep quality and fatigue is still not fully elucidated. to evaluate the effect of improved sleep quality on fatigue, a randomized controlled and cross-over trial with nasal continuous positive airway pressure (ncpap) is carried out in patients who present with a primary complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index (ahi) \>= 15 on polysomnography (psg). the aim of this study is to address the issue of continuous positive airway pressure-responsiveness regarding fatigue as a presenting symptom in cf and cfs patient with obstructive sleep apnea (osa), in the absence of underlying medical or psychiatric illness. the answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. we also want to investigate the continuous positive airway pressure responsiveness regarding sleepiness and general health in the same target population. zero-hypothesis: there is no effect.


Eligibility criteria:
inclusion criteria: * patients primarily referred for disabling, unexpected fatigue. * according to the fukuda criteria, diagnostic work-up yields a final diagnosis of chronic fatigue (cf) or chronic fatigue syndrome (cfs). * 18 \<= age \<= 65 * polysomnography test (psg) demonstrates an apnea-hypopnea index (ahi) \>=15, as evidence for obstructive sleep apnea (osa). * female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the continuous positive airway pressure (cpap) trial and has to employ an acceptable method of birth control. * written, signed and dated informed consent must be obtained from each patient. * patient able to understand and follow the requirements of the study and to comply. * willing to abstain from taking any medication or treatment prohibited in the protocol. exclusion criteria: * patients primarily referred for excessive daytime sleepiness (eds) or snoring. * fatigue that is explained by medical or psychiatric causes. * 18 \> age \> 65 * apnea-hypopnea index (ahi) \< 15 * body mass index (bmi) \>= 40, calculated as weight(m)/(height (m))² * parasomnia * severe sleepiness with (epworth sleepiness scale) ess \>= 16 (=15% of the chronic fatigue syndrome (cfs) population) * tonsillar hypertrophy (friedman grade iii and iv tonsils) * signs of nasal obstruction, including chronic use of topical nasal drugs. * earlier cpap treatment * physical and mental disability that compromises the normal use of cpap * cpap intolerance * current use of sedative (benzodiazepine and non-benzodiazepine gaba-esgic agonist) or antidepressant medication for a time period inferior to 3 weeks. * female patient who is pregnant, lactating or has a positive pregnancy test result.